Challenge: A precision medicine startup with limited resources needed to establish an ISO 13485-compliant QMS to support CE marking of their first advanced NGS diagnostic test under IVDR.

Solution: MDx implemented a staged QMS development approach, prioritizing key processes needed for immediate regulatory requirements while building a scalable framework for future growth.

Result: ISO 13485 certification achieved within 6 months with zero major nonconformities, enabling the client to proceed with IVDR technical documentation submission on schedule.